Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

National Drug Code

Is NDC 0135-0511-03 recalled?

Nicorette

Yes — this exact package was recalled

1 FDA recall names the code 0135-0511-03 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
nicotine polacrilex
Strength
NICOTINE 4 mg/1
Form
Lozenge · Oral
Labeler
Haleon US Holdings LLC
Type
Human OTC Drug
Product code
0135-0511

Recalls naming this package

Class III · Low risk

Nicotine polacrilex lozenge

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Terminated Wrong potency / content GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1243-2014
Class III · Low risk

Nicotine polacrilex lozenge

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Terminated Wrong potency / content GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1240-2014

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler